Cleared Special

1012WCC, 1012WGC

K162518 · Rayence Co., Ltd. · Radiology
Oct 2016
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K162518 is an FDA 510(k) clearance for the 1012WCC, 1012WGC, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Rayence Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on October 6, 2016, 27 days after receiving the submission on September 9, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K162518 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2016
Decision Date October 06, 2016
Days to Decision 27 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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